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ThrombosisPhase 1NCT03769831

The PK/PD Study of SHR2285 Tablets in Healthy Subjects

A Phase 1 study testing SHR2285 in people with Thrombosis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Thrombosis
What is being tested?
SHR2285
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteChina
Study dates
25 Feb 2019to 22 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • males or females, aged 18-45
  • subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg and 50mmHg ≤DBP<90mmHg;
  • body mass index (BMI) between 18 to 28, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg
  • Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Who cannot join

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1X ULN during screening/baseline;
  • Abnormal coagulation function;
  • A clinical history of coagulation dysfunction；subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
  • Subjects with severe trauma or surgery within 3 months prior to the screening；
  • Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;
  • Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
  • 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;
  • Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

Other trials in China

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects

Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.

Conditions
Thrombosis
Being tested
SHR2285, Placebo
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR2285Drug

    Ascending dose oral adminstration

  • PlaceboDrug

    Ascending dose oral adminstration

Study groups in NCT03769831
Study groupRoleWhat they receive
SHR2285ExperimentalUp to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.
Receives: Drug: SHR2285
PlaceboExperimentalUp to 7 cohorts of healthy subjects will receive a single dose of oral placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events and serious adverse events

    Measured: Pre-dose to 7 days after dose administration

Secondary outcomes (8)

  1. Area under the plasma concentration versus time curve (AUC) of SHR2285

    Measured: Pre-dose to 2 days after dose administration

  2. Maximum observed serum concentration (Cmax) of SHR2285

    Measured: Pre-dose to 2 days after dose administration

  3. Time to maximum observed serum concentration (Tmax) of SHR2285

    Measured: Pre-dose to 2 days after dose administration

  4. Time to elimination half-life (T1/2) of SHR2285

    Measured: Pre-dose to 2 days after dose administration

  5. Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285

    Measured: Pre-dose to 2 days after dose administration

  6. Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285

    Measured: Pre-dose to 2 days after dose administration

  7. Mean Residence Time(MRT) of SHR2285

    Measured: Pre-dose to 2 days after dose administration

  8. Change of APTT, PT, INR from baseline.

    Measured: during Pre and Post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2018
  2. Study start25 Feb 2019
  3. Primary completion22 Jul 2019
  4. Study completion22 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03769831
Sponsor's protocol ID
SHR2285-101
Status last verified
Dec 2018
First submitted
6 Dec 2018
Last updated
24 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen R, Guan X, Hu P, Dong Y, Zhu Y, Zhang T, Zou J, Zhang S. First-In-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, a Small-Molecule Factor XIa Inhibitor in Healthy Subjects. Front Pharmacol. 2022 Feb 10;13:821363. doi: 10.3389/fphar.2022.821363. eCollection 2022.

    PubMed 35222036

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR2285 in people with Thrombosis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse events and serious adverse events (time frame: Pre-dose to 7 days after dose administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769831, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.

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